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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Used in risk assessment report for ZnSO4, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): zinc sulphate (ZnSO4.7H2O)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No information

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g of the moistened test material was applied
Duration of treatment / exposure:
4 h
Observation period:
At 1, 24, 48 and 72 h after the exposure
Number of animals:
Three
Details on study design:
No further details

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: not applicable
Irritant / corrosive response data:
No skin irritation/corrosion were observed
Other effects:
No symptoms of systemic toxicity and no mortality occurred

Any other information on results incl. tables

None       

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No symptoms of systemic toxicity and no skin irritation/corrosion were observed and no mortality occurred.
Executive summary:

In a well-performed primary skin irritation/corrosion study, conducted according to Directive 92/69/EEC B.4 and OECD guideline 404, three male New Zealand White rabbits were exposed to 0.5 g of moistened zinc sulphate (ZnSO4.7 H2O), applied onto clipped skin for 4 h using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 h after exposure. No symptoms of systemic toxicity and no skin irritation/corrosion were observed and no mortality occurred.